MUSC Health first to resume COPD trial

In the midst of the coronavirus pandemic, MUSC Health is the first medical center in the world to restart a clinical trial meant to help people with chronic obstructive pulmonary disease.

“We’re thoughtfully re-engaging in a safe program,” said Charlie Strange, M.D., a professor of pulmonary and critical care medicine. MUSC Health is luckier than some other medical centers in that the pandemic hasn’t hit as hard here, and the hospital system is able to get back to clinical trials – which can make a big difference to patients’ lives.

This trial, for example, is the third phase of testing a procedure that should make breathing easier and reduce the number of exacerbations, or flare-ups, for people with COPD.

 

Aiken resident Les Hall, who has lived with COPD since the early 2000s, has the distinction of being the first COVID-era patient to undergo the procedure, called targeted lung denervation. He’s hopeful it will prevent the flare-ups that plagued him in 2019 and allow him to continue enjoying activities like golf.

“I’m hoping to see a slight improvement,” he said. “I’m not looking to become a long-distance swimmer or anything like that. If I get a little improvement in my breathing capacity, that's wonderful. If this keeps me plateaued at this level for a longer period of time, that’s great.”

Hall said the progression of his COPD was so gradual that it’s hard to pinpoint a time when it became noticeably worse. Looking back, though, he notes that he stopped mowing the lawn about four years ago because the effort was too much. Last year, he suffered through several exacerbations. He went from playing three or four rounds of golf each week to only about 20 rounds all year. Pulmonary rehabilitation enabled him to enjoy a planned trip to Europe, although he couldn’t walk around historic sites for as long as he would have liked.

When Strange’s office contacted him in January to ask if he’d be interested in participating in this trial, he jumped at the chance. Then the novel coronavirus pandemic intervened, forcing a pause to many clinical trials, so it wasn’t until May 27 that he was able to get the treatment.

The procedure and the instrumentation necessary to perform it were developed by Nuvaira, a privately held medical device company headquartered in Minneapolis, Minnesota.

During the hour-long procedure, a doctor threads a special catheter into the lungs, then uses radio frequency to destroy small parasympathetic nerves. These nerves are believed to control airway tone and the development of mucus, Strange explained. By quieting these overactive nerves, the airway relaxes and less mucus is created.

Mucus is thought to be the No. 1 cause of exacerbations, Strange said. During an exacerbation, the patient’s symptoms become markedly worse, or the patient could even develop new symptoms.

“These exacerbations are what take people to emergency rooms and hospitals. And exacerbations of COPD cost $50 billion a year in the United States,” he said.

Strange said that medicines typically prescribed for COPD, called bronchodilators, open up the airway by interacting with nerve receptors. The procedure isn’t a replacement for medication but instead boosts its power, since there are fewer receptors to interact with.

“With one hour’s worth of work, we can open up your airways and make them responsive to the medicines we give as bronchodilators,” he said. “We do see higher lung function, but the real goal is to turn on a therapy that will stop exacerbations from happening and really improve global quality of life over the years.”

 

To avoid hitting the vagus nerve and potentially causing stomach or bowel problems, dye is inserted into the patient’s esophagus so the doctor can monitor its location using fluoroscopy, a real-time X-ray, during the procedure. This aspect of Hall’s procedure yielded information that could be useful in the future, Strange said. He was able to use the radio frequency on only a quarter of the airway on Hall’s right side because his esophagus was too close. However, he noted that when the team rolled Hall onto his side, the esophagus moved. He’s proposed to Nuvaira that future patients with a similar issue should be able to get the full treatment by physically shifting their positions.

Hall said he wasn’t sure what to expect in terms of pain, but he was pleasantly surprised that upon returning to the hotel after the outpatient procedure, he was able to eat a chicken sandwich, followed by lasagna for dinner. He was also pleased with the attentive care of the MUSC Health team.

“The staff there was wonderful. Everybody that was there to help and to do something with or for me came by and introduced themselves before the procedure and told me what they were going to do,” he said. “I was very impressed by that. Everybody's busy, and they’ve got things to do, but they took time to make this personal.”

He was also happy to get back to the golf course on the Sunday after his procedure. Most of all, he’s hopeful that his experience will help other patients with COPD.

“If nothing else, I hope this is something that can help people in the future,” Hall said. “Maybe I'm a small part of that; that my legacy would be that I was one who took a chance and said, ‘Yeah, go ahead… so others can benefit further down the road.’”